On April 25 2016 Ipsen (Euronext: IPN; ADR: IPSEY) reported that its partner Exelixis, Inc. (NASDAQ:EXEL) received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) tablets earlier today for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy (Press release, Ipsen, APR 25, 2016, View Source [SID:1234511439]). On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan.

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RCC is the most common form of kidney cancer in adults. The incidence of advanced RCC is estimated to be around 20,000 new patients per year in Ipsen’s territories.

CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate in a large, randomized phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival, progression free survival and objective response rate.

Compared with everolimus, CABOMETYX is associated with a 42 percent reduction in the rate of disease progression or death and 34 percent reduction in the rate of death. Median progressionfree survival for CABOMETYX is 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Median overall survival is 21.4 months for patients receiving CABOMETYX versus 16.5 months for those receiving everolimus (HR=0.66, 95% CI 0.53-0.83, P=0.0003).

In Europe, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment. With this designation, the MAA is eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA).

Exelixis press release is available here: http://bit.ly/24gckfO

On April 25, 2016 Merck, a leading science and technology company, reported that the pivotal Chinese Phase III TAILOR study met its primary endpoint of significantly increasing progression-free survival (PFS) in patients with RAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux (cetuximab) plus FOLFOX chemotherapy, compared with FOLFOX alone (Press release, Merck & Co, APR 25, 2016, View Source;newsType=1 [SID:1234511390]).

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"We are thrilled with the TAILOR results that bring a major contribution to the available scientific evidence of Erbitux’s efficacy in combination with FOLFOX as a standard first-line treatment for patients with RAS wild-type metastatic colorectal cancer. This marks a significant step in the execution of our strategy in oncology, notably the expansion in growth markets like China," said Luciano Rossetti, Head of Global Research and Development of Merck’s biopharma business. "These impressive results reinforce the value and imperative of RAS biomarker testing in clinical practice, so as to provide patients with the right targeted therapy. These results also underscore why we continue to devote our efforts towards both improving testing and ensuring access to Erbitux worldwide." 1–4

The clinical benefit that Erbitux offers to RAS wild-type mCRC patients is further strengthened by the secondary endpoint results, which support the superiority shown for PFS. The safety profile of Erbitux in the TAILOR clinical trial was manageable and similar to that observed in other pivotal trials, with no unexpected safety findings. The full study results will be submitted to upcoming international scientific meetings.

Both the National Comprehensive Cancer Network (U.S.) and the European Society for Medical Oncology clinical guidelines recommend first-line treatment with Erbitux plus FOLFOX or FOLFIRI for patients with RAS wild-type mCRC.5,6

"We are excited that the TAILOR study is positive and that Erbitux in combination with chemotherapy could become a new first-line treatment option for metastatic colorectal cancer patients in China, once approved," said Professor Shukui Qin from Nanjing Bayi Hospital, China, Coordinating Investigator in the TAILOR study. "It is also reassuring that the results reflect those previously observed, and support the indicated first-line use of Erbitux plus FOLFOX in many countries."

Erbitux has obtained marketing authorization in over 90 countries worldwide. In Europe, Erbitux is indicated as first-line therapy for patients with RAS wild-type mCRC tumors, together with the oxaliplatin-containing regimen FOLFOX in treatment-naïve patients or together with regimens containing irinotecan (e.g. FOLFIRI).7 More than 442,000 patients with mCRC have been treated with Erbitux.

About the TAILOR study
The TAILOR study is a Phase III, open-label, randomized, controlled, multicenter trial designed to compare Erbitux in combination with FOLFOX-4 versus FOLFOX-4 alone in the first-line treatment of Chinese patients with RAS wild-type mCRC. All randomized subjects were planned to receive treatment until the occurrence of progressive disease (PD) or unacceptable toxicity. The study enrolled 397 patients with RAS wild-type mCRC. The primary endpoint of the trial is progression-free survival. Secondary endpoints include: overall survival, best overall response rate, time to treatment failure and rate of curative surgery for liver metastases.

About mCRC
Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.8 Results from studies assessing RAS mutation status in patients with mCRC have shown that antiepidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.1-4 Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.9 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.9 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.9

About Erbitux
Erbitux is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard nonselective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

Ocrelizumab is a humanized monoclonal antibody that selectively targets the CD20-positive B-cells implicated in the inflammatory and neurodegenerative processes of multiple sclerosis (MS), to effectively impact disease progression while maintaining immunosurveillance (Company Pipeline, Hoffmann-La Roche , APR 25, 2016, View Source [SID:1234511389]).

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On April 25, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported results for the quarter ended March 31, 2016 (Press release, LabCorp, APR 25, 2016, View Source;p=RssLanding&cat=news&id=2160874 [SID:1234511377]).

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"We are off to a terrific start to the year, highlighted by robust organic revenue growth and double-digit adjusted EPS growth in the quarter," said David P. King, chairman and chief executive officer. "Broad-based demand for the services of LabCorp Diagnostics and Covance Drug Development is evidence of our customers’ enthusiasm for our differentiated offering. We continue to carry out our mission to improve health and improve lives through focus on three key strategic objectives – delivering world class diagnostics, bringing innovative medicines to patients faster and changing the way care is provided."

Consolidated Results

Net revenue for the quarter was $2.30 billion, an increase of 29.5% over last year’s $1.77 billion. The Covance acquisition contributed $687.3 million in net revenue during the quarter, compared to $267.2 million in the first quarter of 2015 following the date of closing on February 19, 2015, driving an increase of 23.7% year over year due to strong demand and the inclusion of Covance’s financial results for the entire quarter. LabCorp Diagnostics contributed the remainder of the increase of $102.8 million, or 5.8%, primarily due to solid organic growth and tuck-in acquisitions, partially offset by the impact from currency.

Operating income for the quarter was $301.9 million, compared to $132.4 million in the first quarter of 2015. The Company recorded restructuring charges and special items of $29.3 million in the quarter, compared to $138.7 million during the same period in 2015. Adjusted operating income (excluding amortization of $44.3 million, restructuring and special items) for the quarter was $375.5 million, or 16.4% of net revenue, compared to $302.2 million, or 17.1%, in the first quarter of 2015. The increase in adjusted operating income was primarily due to strong revenue growth and productivity, partially offset by personnel costs and bad debt. The decline in margin was primarily due to the mix impact from the inclusion of Covance’s financial results for the entire quarter.

Net earnings in the quarter were $160.2 million, or $1.55 per diluted share, compared to $3.1 million, or $0.04 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $2.02 in the quarter, an increase of 14.8% compared to $1.76 in the first quarter of 2015. The Company’s results included a net gain in the quarter of $0.05 per diluted share on the sale of investment securities from its venture fund.

Operating cash flow for the quarter was $123.0 million, compared to negative $86.9 million last year. The Company’s operating cash flow in the first quarter of 2015 was negatively impacted by $153.5 million in non-recurring items relating to the acquisition of Covance. Excluding these items, operating cash flow was $66.6 million last year. The increase in operating cash flow was primarily due to improved earnings. Capital expenditures totaled $71.4 million, compared to $33.8 million in the first quarter of 2015. As a result, free cash flow (operating cash flow less capital expenditures) was $51.6 million, compared to negative $120.7 million in the first quarter of 2015. Excluding non-recurring items, free cash flow was $32.8 million last year.

At the end of the quarter, the Company’s cash balance and total debt were $696.3 million and $6.4 billion, respectively. During the quarter, the Company invested $93.3 million in tuck-in acquisitions.

The following segment results are presented on a pro forma basis for all periods as if the acquisition of Covance closed on January 1, 2015 and exclude amortization, restructuring, special items and unallocated corporate expenses. Reconciliations of segment results to historically reported results are included in the Condensed Pro Forma Segment Information tables and notes.

Pro Forma Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.59 billion, an increase of 7.2% over $1.48 billion for the first quarter of 2015. The increase in net revenue was the result of organic volume growth (measured by requisitions), Beacon LBS, price, mix and tuck-in acquisitions, partially offset by currency. The increase in net revenue of 7.2% includes the benefit from Beacon LBS of 1.0%, and unfavorable foreign currency translation of 0.6%. Total volume (measured by requisitions) increased by 4.0% (organic volume of 3.4% and acquisition volume of 0.6%). Revenue per requisition increased by 2.7%.

Adjusted operating income (excluding amortization, restructuring and special items) for the quarter was $310.3 million, or 19.5% of net revenue, compared to $289.6 million, or 19.5% of net revenue, in the first quarter of 2015. The increase was primarily due to volume, price, mix and productivity, partially offset by personnel costs and bad debt. Improvement in productivity was driven by Project LaunchPad, the Company’s business process improvement initiative, which remains on track to deliver net savings of $150 million through the three-year period ending in 2017.

Covance Drug Development

Net revenue for the quarter was $703.1 million, an increase of 12.6% over $624.6 million for the first quarter of 2015 due to broad-based demand. The stronger U.S. dollar negatively impacted year-over-year revenue growth by approximately 160 basis points. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue increased 17.9% year over year.

Adjusted operating income (excluding amortization, restructuring and special items) was $103.3 million, or 14.7% of net revenue, compared to $74.2 million, or 11.9% of net revenue, in the first quarter of 2015. The increase was primarily due to demand, productivity and cost synergies, partially offset by the expiration of the Sanofi site support agreement and personnel costs. The Company remains on track to deliver cost synergies of $100 million related to the acquisition of Covance through the three-year period ending in 2017.

During the quarter, net orders (gross orders less cancellations and reductions) were $830 million, representing a net book-to-bill of 1.18.

Outlook for 2016

The following updated guidance assumes foreign exchange rates effective as of March 31, 2016 for the remainder of the year.

Net revenue growth of 8.5% to 10.5% over 2015 net revenue of $8.51 billion, which includes the impact from approximately 40 basis points of negative currency. This is an increase from prior guidance of 7.5% to 9.5%, which included approximately 100 basis points of negative currency.
Net revenue growth in LabCorp Diagnostics of 4.0% to 5.5% over 2015 pro forma revenue of $6.21 billion, which includes the impact from approximately 20 basis points of negative currency. This is an increase from prior guidance of 3.5% to 5.5%, which included approximately 50 basis points of negative currency.
Net revenue growth in Covance Drug Development of 6.0% to 9.0% over 2015 pro forma revenue of $2.63 billion, which includes the impact from approximately 50 basis points of negative currency. This is an increase from prior guidance of 2.0% to 5.0%, which included approximately 200 basis points of negative currency. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue is expected to increase approximately 9% to 12%.
Adjusted EPS of $8.55 to $8.95, versus prior guidance of $8.45 to $8.85, and as compared to $7.91 last year.
Free cash flow (operating cash flow less capital expenditures) of $900 million to $950 million, an increase of approximately 24% to 31% over the prior year, unchanged from prior guidance.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including Adjusted EPS, Adjusted Operating Income, and Free Cash Flow. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing its Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available on the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

On April 25, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that its SL-401 Phase 2 clinical data update was selected for oral presentation on June 4, 2016 at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Stemline Therapeutics, APR 25, 2016, View Source [SID:1234511376]).

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Details on the presentation are as follows:

Title:
Results from Phase 2 registration trial of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Lead-in completed, Expansion stage ongoing.
Presenter: Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.: 7006
Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date/Time: Saturday, June 4, 2016; 5:00 – 5:12PM CT
Location: Arie Crown Theater

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are honored that ASCO (Free ASCO Whitepaper) has selected our Phase 2 data update for an oral presentation at this year’s annual meeting. We are also privileged to be working with world-class collaborators and institutions on this important trial and look forward to Dr. Pemmaraju’s presentation and data updates at the meeting."